Propyl Gallate

The Food and Drug Administration (FDA) reviewed the safety of Propyl Gallate and determined that it was Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) for use as an antioxidantIngredients that prevent or slow deterioration due to chemical reaction with oxygen. at a maximum concentration of 0.02% of the fat or oil content of the food. The safety of Propyl Gallate has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel.

The CIR Expert Panel evaluated the scientific data and concluded that Propyl Gallate was safe in the practices of use in cosmetics and personal care products at concentrations less than or equal to 0.1%.

CIR Safety Review: The CIR Expert Panel noted that little systemic toxicity was associated with oral or dermal exposure to Propyl Gallate. Rather than resulting in adverse effects, laboratory studies using oral exposure to Propyl Gallate showed preventive effects, including a reduction in cancer, birth defects and cavities of the teeth. These positive effects were consistent with the ability of Propyl Gallate to scavenge free radicals. 

Propyl Gallate has been shown to be a dermal sensitizer. Sensitization occurred at concentrations of Propyl Gallate of 1% and greater.

The CIR Expert Panel noted that in actual practice, cosmetics and personal care products were reported to contain Propyl Gallate at concentrations up to 0.1%.

Clinical experience by members of the CIR Expert Panel has not included observations of sensitization reactions from Propyl Gallate in cosmetics and personal care products. Because of the potential for sensitization, the CIR Expert Panel set a concentration limitation of 0.1% for Propyl Gallate use in cosmetic and personal care products.

FDA: Link to Code of Federal Regulations for Propyl Gallate http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Propyl Gallate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-1.4 mg/kg body weight for Propyl Gallate.

http://www.inchem.org/documents/jecfa/jeceval/jec_2042.htm